MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSIST) DEVICE

Model Number 106524US

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Renal Failure (2041); Thrombosis/Thrombus (4440)

Event Date 09/01/2021

Event Type  Injury  

Event Description

It was reported through the research article ¿mechanical pump complication after heartmate 3 implantation¿ that heartmate 3 (hm3) may be associated with bleeding, stroke, renal failure, respiratory insufficiency, pump thrombosis, outflow graft obstruction, and death.This single-center retrospective study evaluated mechanical pump complications and secondary outcomes in 141 adult patients implanted with a hm3 with the ¿cut-then-sew¿ implantation technique between sep2015 and sep2021.Mechanical pump complications were defined in the article as pump failure secondary to outflow graft compression, outflow graft obstruction, or pump thrombosis and requiring surgical intervention.Results reported 11 patients developed mechanical pump complications.A total of 6 patients experienced an outflow graft obstruction; 4 patients experienced a proteinaceous external compression, and 2 patients experienced an outflow graft twist.A total of 5 patients experienced acute pump thrombosis; 4 patients were found to have the thrombus in their inflow cannula at time of intervention, and the location of thrombus in 1 patient could not be determined.Of these 11 patients with mechanical pump complications, 4 underwent an outflow graft revision, 1 patient required an extracorporeal membrane oxygenator (ecmo) and then underwent a heart transplant, and 6 patients underwent a pump exchange.A total of 10 patients were noted to have survived to discharge following surgical intervention for mechanical complications.Freedom from mechanical pump complications at 1, 3, and 5 years was 97.7%, 90.2%, and 86.7% respectively.The median time to a mechanical complication was 828 days.Several secondary outcomes were reported of the 141 evaluated patients.A total of 6 patients experienced bleeding in the early postoperative period.Two patients had massive bleeding within the first 24 hours and were both taken back to the operating room.The source of bleeding could not be determined for one patient, and the other patient had bleeding from a sternal wire.The other 4 patients who experienced bleeding required blood transfusions for greater than 7 days post-implant.A total of 3 patients experienced stroke: an ischemic stroke in several vascular distributions, a large middle cerebral artery stroke, and a hemorrhagic stroke one month post-implant.A total of 29 patients experienced renal failure during the postoperative period.A total of 26 patients required reintubation.Median ventilation time was 29 hours.Median intensive care unit stay was 11.6 days, and median overall hospitalization was 32 days.A total of 16 patients died during the implant hospitalization, attributed to postoperative complications.Overall survival at 1, 3, and 5 years was 82.9%, 69.1%, and 55.2% respectively.Related manufacturer's reference number for death on the pump: 2916596-2024-01286.Related manufacturer's reference number for mechanical pump complications: 2916596-2024-01284.

Manufacturer Narrative

Sections a, d4: specific patient information and device serial number were documented as unknown.The device was implanted at time of event.Section b3: date of event is approximate as the data was collected between sep2015 and sep2021.Author information: merlo, a., tasoudis, p., de oliveira, g.C., ikonomidis, j.S., tessmann, p., haithcock, b., & caranasos, t.(2023).Mechanical pump complication after heartmate 3 implantation.Journal of thrombosis and thrombolysis, 57(1), 82¿88.Https://doi.Org/10.1007/s11239-023-02892-w, department of surgery, university of north carolina at chapel hill, 4005 burnett-womack, cb #7050, chapel hill, nc 27599-7050, usa.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Manufacturer Narrative

E1: reporter - (b)(6).Manufacturer¿s investigation conclusion.A direct correlation between the heartmate 3 left ventricular assist system (lvas) devices in use and the reported events cannot be conclusively determined.The serial numbers of the heartmate 3 devices were not reported.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1, "introduction," lists the adverse events, including thromboembolism, stroke, bleeding respiratory dysfunction, and renal dysfunction, as adverse events that may be associated with the use of heartmate 3 lvas.Section 6, ¿patient care and management¿, also lists thromboembolism as a potential late postimplant complication.Section 6, ¿patient care and management¿ (under ¿anticoagulation¿), provides the recommended anticoagulation regimen, including international normalized ratio (inr) range, as well as suggested anticoagulation modifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSIST) DEVICE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18923251
• MDR Text Key: 337893855
• Report Number: 2916596-2024-01285
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106524US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention